Public assurances over safety of schoolgirl vaccinations

HEALTH officials have moved to assure the public about the safety of a vaccine to protect girls from cervical cancer after schools got letters claiming it was contaminated.

Second-level schools with female students have been facilitating the HPV (human pappillomavirus) immunisation programme for the Health Service Executive (HSE) since before last year’s summer holidays. It is administered in three doses and more than 145,000 doses have been given to date, mostly to girls in first and second year, but a catch-up programme is extending it to sixth-year students.

The HSE wrote to all second-level schools this week after learning of correspondence being sent to principals with concerns that Gardasil, the vaccine used in the programme, is “contaminated with viral DNA”. It is unknown how many schools received the letters, if they are in a particular region, or if the sender was identified.

US group SANE Vax Inc said on September 6 that it found recombinant HPV DNA in 13 Gardasil vials it had tested. It has asked the Food and Drug Administration (FDA) to investigate.

The European Medicines Agency is reviewing the information but the Irish Medicines Board (IMB), which regulates vaccines here, said initial evaluations suggest the balance of benefits and risks for Gardasil is unaffected and remain positive. “This information has no impact on the safety or effectiveness of the vaccine,” an IMB spokesperson told the Irish Examiner last.

HSE assistant national director of population health Dr Kevin Kelleher told schools the IMB and EU agencies will continue to monitor Gardasil.

“Any recommendations arising from this will be notified to you. There is no change to the vaccine programme and the benefits of the vaccine remain positive,” he wrote.

The HPV virus is transmitted sexually so the vaccine is most effective if given to girls who have not been sexually active, but there have been claims that its use encourages sexual activity by teenagers. The Irish Examiner has learned of some Catholic secondary schools receiving calls to say it is immoral to allow girls be immunised.

More than 70% of cases of cervical cancer, diagnosed in 250 women and killing around 80 in Ireland every year, are linked to HPV types covered by Gardasil.

More than 80% of girls who were in first and second year have had all three doses of the vaccination since May 2010. Most of the 416 adverse events reported — less than 0.3% of the number of doses — up to the end of June were non-serious. Five people had seizures, including two who had epilepsy. Six had anaphylactic reactions, a very rare side effect of most vaccines, but the IMB said they all recovered after treatment.